1. Field of the Invention
The present invention generally relates to a diagnostic kit and more specifically to a self contained diagnostic kit providing analysis of a sample by a sample collecting element and an immunochromatography test strip.
2. Discussion of the Related Art
Flow test strips are most commonly used for the last thirty years. The test strips are used for the specific qualitative or semi-quantitative detection of many analytes including antigens, antibodies, and even the products of nucleic acid amplification tests. One or several analytes can be tested for simultaneously on the same strip. Urine, saliva, serum, plasma, or whole blood can be used as samples. Extracts of patient exudates or fluids have also been successfully used.
Test sensitivity can be quite good. For example, hepatitis B surface antigen (HBsAg) test strips have claimed a sensitivity of 1.0 ng HBsAg/ml or less. Test specificity can also be very high. The tests use colloidal gold, dye, or latex bead conjugates to generate signal. The assembled strips are dried and packaged, making them stable for months when properly protected from moisture and excessive heat.
To perform the test, a sample either used alone or with an extraction reagent or a running buffer is placed on the sample pad on one end of the strip. The signal reagent is solubilized and binds to the antigen or antibody in the sample and moves through the membrane by capillary action. If specific analyte is present, the signal reagent binds to it, and a second antibody or antigen-immobilized as a line in the nitrocellulose then captures the complex. If the test is positive, a pink/purple line develops. Once the specimen is added, the tests can be left unattended until they are read. The tests can be run individually or in limited-size batches. Results can usually be read in 5 to 15 minutes. All tests include an internal procedural control line that is used to validate the test result. Appearance of two lines, therefore, indicates a positive result, while a negative test produces only one line.
Diagnosis of certain conditions at the oral, genital and rectal cavities (i.e Candida, Bacterial Vaginosis, colon cancer, HPV) require a sample taken by a swab or other collecting applicators before testing for the analyte using test strips. Collecting a sample is followed by an action aimed to preserve the sample from being contaminated and to keep sample's qualities (e.g. stability and arrangement of all components). Preserving a sample can be secured by placing the sample in a sterile container, or alternatively, placing the sample within a preserving liquid. Preserving sample after collecting it is necessary because the diagnosis of analytes within sample is not done immediately after sample's collection. Moreover, analysis of samples using test strips is usually performed not on the site of sample collection. The next step is placing the sample on a sample pad on one end of the strip. Furthermore, analyzing a sample with a test strip often requires the placing of the sample within an extraction reagent or running buffer, which is placed on the sample pad. Placing a sample on a sample pad requires appropriate training. Consequently, sample collection is performed by personnel other than the personnel performing the analysis of the sample. Naturally, due to different causes (e.g. misplacement and swapping of samples, unsuitable conditions) the time and distance intervals jeopardize the accuracy of the diagnosis. Hence, there is a need for a diagnosis kit enabling accurate on-site analysis of the sample.
Recent prior art discloses a diagnostic kit having a diagnostic strip placed within a tubular container. The kit requires first the placing of a specimen on swab tip within the tubular container, and followed by placing a removable cap that contains a reagent. Then, adding the reagent for initiating an analysis of the specimen. The requirement to add reagent to the tubular container requires concentration and accuracy performed preferably by experienced laboratory staff for a successful diagnosis. Furthermore, adding the reagent will occur sometime after the collection of the sample and usually at remote location from the sample collecting location rather than immediately after collecting a sample. Thus the prior art does not disclose a self contained diagnostic kit due to the fact that additional action is required after the specimen is collected and inserted in tubular container.
Furthermore, there are ever increasing requirements of public health authorities worldwide aiming to provide simple and accurate test kits for self use by layman. For example, the U.S. Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. Thus, On Feb. 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
Therefore there is a need to provide a completely self contained diagnostic kit. Furthermore, there is a need to provide a diagnostic kit that does not require special training for initiating analysis after insertion of sample. There is a need to provide a simple constructed self contained diagnostic kit. The above advantages as well as other are included in various embodiments of the disclosed invention.